US7799064B2 - Bifurcated stent and delivery system - Google Patents

Abstract

Systems for delivering a bifurcated stent to a bifurcation site comprise catheters and/or bifurcated stents delivered therefrom.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. provisional applications No. 60/271,506 filed Feb. 26, 2001; U.S. provisional application No. 60/271,602 filed Feb. 26, 2001; and U.S. provisional application No. 60/271,595 filed Feb. 26, 2001; the entire content of each being incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable

BACKGROUND OF THE INVENTION

Stents, grafts, stent-grafts, vena cava filters and similar implantable medical devices, collectively referred to hereinafter as stents, are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously. Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, etc. Stents may be used to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system. They may be self-expanding or expanded by an internal radial force, such as when mounted on a balloon.

Stents are generally tubular devices for insertion into body lumens. Balloon expandable stents require mounting over a balloon, positioning, and inflation of the balloon to expand the stent radially outward. Self-expanding stents expand into place when unconstrained, without requiring assistance from a balloon. A self-expanding stent is biased so as to expand upon release from the delivery catheter. Some stents may be characterized as hybrid stents which have some characteristics of both self-expandable and balloon expandable stents.

Stents may be constructed from a variety of materials such as stainless steel, Elgiloy, nitinol, shape memory polymers, etc. Stents may also be formed in a variety of manners as well. For example a stent maybe formed by etching or cutting the stent pattern from a tube or section of stent material; a sheet of stent material maybe cut or etched according to a desired stent pattern whereupon the sheet may be rolled or otherwise formed into the desired tubular or bifurcated tubular shape of the stent; one or more wires or ribbons of stent material may be braided or otherwise formed into a desired shape and pattern.

A vessel having a stenosis may be viewed as an inwardly protruding arcuate addition of hardened material to a cylindrical vessel wall, where the stenosed region presents a somewhat rigid body attached along, and to, the elastic wall. The stenosis presents resistance to any expansion of the vessel in the region bridged by the stenosis. Stenoses vary in composition, for example, in the degree of calcification, and therefore vary in properties as well.

A stent may be used to provide a prosthetic intraluminal wall e.g. in the case of a stenosis to provide an unobstructed conduit for blood in the area of the stenosis. An endoluminal prosthesis comprises a stent which carries a prosthetic graft layer of fabric and is used e.g. to treat an aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of embolism, or of the natural artery wall bursting. Typically, a stent or endoluminal prosthesis is implanted in a blood vessel at the site of a stenosis or aneurysm by so-called “minimally invasive techniques” in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required through the patient's skin or by a “cut down” technique in which the blood vessel concerned is exposed by minor surgical means. When the stent is positioned at the correct location, the catheter is withdrawn and the stent is caused or allowed to re-expand to a predetermined diameter in the vessel.

U.S. Pat. No. 4,886,062 discloses a vascular stent which comprises a length of sinuous or “zig-zag” wire formed into a helix; the helix defines a generally cylindrical wall which, in use, constitutes a prosthetic intraluminal wall. The sinuous configuration of the wire permits radial expansion and compression of the stent; U.S. Pat. No. 4,886,062 discloses that the stent can be delivered percutaneously and expanded in situ using a balloon catheter.

U.S. Pat. No. 4,733,665 discloses an expandable intraluminal graft which is constituted by a tubular member formed from a plurality of intersecting elongate members which permit radial expansion and compression of the stent.

EP-A-0556850 discloses an intraluminal stent which is constituted by a sinuous wire formed into a helix; juxtaposed apices of the wire are secured to one another so that each hoop of the helix is supported by its neighboring hoops to increase the overall strength of the stent and to minimize the risk of plaque herniation; in some embodiments the stent of EP-A-0556850 further comprises a tubular graft member to form an endoluminal prosthesis.

The devices cited above are generally satisfactory for the treatment of aneurysms, stenoses and other angeological diseases at sites in continuous unbifurcated portions of arteries or veins.

Within the vasculature however it is not uncommon for stenoses to form at a vessel bifurcation. A bifurcation is an area of the vasculature or other portion of the body where a first (or parent) vessel is bifurcated into two or more branch vessels. Where a stenotic legion or legions form at such a bifurcation, the lesion(s) can affect only one of the vessels (i.e., either of the branch vessels or the parent vessel) two of the vessels, or all three vessels. Many prior art stents however are not wholly satisfactory for use where the site of desired application of the stent is juxtaposed or extends across a bifurcation in an artery or vein such, for example, as the bifurcation in the mammalian aortic artery into the common iliac arteries.

In the case of an abdominal aortic aneurysm (“AAA”) in the infrarenal portion of the aorta which extends into one of the common iliac arteries, the use of one of the prior art prosthesis referred to above across the bifurcation into the one iliac artery will result in obstruction of the proximal end of the other common iliac artery; by-pass surgery is therefore required to connect the one iliac artery in juxtaposition with the distal end of the prosthesis to the other blocked iliac artery. It will be appreciated by a person skilled in the art that it is desirable to avoid surgery wherever possible; the requirement for by-pass surgery associated with the use of the prior art prosthesis in juxtaposition with a bifurcation in an artery therefore constitutes a significant disadvantage.

Another example of a vessel bifurcation is the left and right common carotid arteries. These arteries are the principal arteries of the head and neck. Both of the common carotid arteries are quite similar and divide at a carotid bifurcation or bulb into an external carotid artery and an internal carotid artery. In the region of the carotid bulb and the ostium of the internal carotid artery, stenoses present a particular problem for carotid stenting due to the large tapering of the vessel interior from the common carotid artery (both the left and the right) to the internal carotid artery. The region of the carotid bifurcation or bulb happens to be where stenoses most often occur, particularly in the region of the ostium to the internal carotid artery in both of the carotid arteries.

Embodiments of the present invention relate to endoluminal prosthesis (stents) that may be utilized in the region of a bifurcation of vessels. The present invention also embraces stent connecting means for connecting a stent (e.g. a stent which forms part of an endoluminal prosthesis or bifurcated stent) to another stent or portion thereof. Some embodiments of the invention are directed to designs of bifurcated stents and their method of manufacture, as well as apparatuses and methods for introducing prostheses to the vasculature and methods of treating angeological diseases.

All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.

Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.

A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.

BRIEF SUMMARY OF THE INVENTION

The present invention includes many different embodiments. Various embodiments of the invention are directed to designs of bifurcated stents and/or the methods and apparatuses utilized to deliver a bifurcated stent to a bifurcation site.

In some embodiments, the invention is directed to a bifurcated stent assembly having a unique engagement mechanism for joining two stent bodies together when in the expanded state. In some embodiments the engagement mechanism may be a plurality of stent members that form a scaffold which extends into the ostium of the secondary vessel when the primary stent body is expanded. The scaffold provides a conduit for the introduction of the secondary stent body into the secondary vessel through the primary stent. The scaffold also provides at least a partial lining of the transition area between the stent bodies. In some embodiments where the scaffold is at least partially constructed from metal, one or more of the members may be at least partially selectively annealed to provide the scaffold with improved flexibility and actuation.

In at least one embodiment of the invention a scaffold equipped primary stent body may be expanded and delivered via a unique inflation member or balloon having a unique geometry. When inflated to expand the primary stent, the geometry of the balloon is characterized by a bulge region that allows the scaffold portion to be expanded prior to or subsequent to the expansion of the rest of primary stent body. In at least one embodiment the bulge region is defined as a thicker or thinner portion balloon wall.

In at least one embodiment the scaffold is defined by a plurality of self-expanding members, wherein the members are constructed and arranged to outwardly expand from the primary stent body to define the side opening and a flow path therethrough.

In at least one embodiment, the invention is directed to a bifurcated stent delivery system that includes a one or more catheter assemblies comprising two guide wires, a primary and secondary guide wire for delivering two stent bodies to a bifurcation of vessels. The catheter (or catheters) is configured to allow a first stent body to be advanced along the first guide wire to the primary vessel of the bifurcation site where it is positioned to extend across the secondary vessel or daughter branch of the bifurcation with a side opening exposed thereto. The secondary guide wire is constructed and arranged to be advanced through the partially expanded first stent body and through the side opening to enter the secondary vessel of the bifurcation. The second stent body may then be advanced along the secondary guide wire through the side opening of the expanded first stent body for positioning into the secondary vessel. In at least one embodiment the stent bodies are configured such that during positioning and/or expansion of the secondary stent body, the secondary body becomes engaged to at least a portion of the first stent body defining the side opening.

In some embodiments the first stent section and/or the second stent section employs one or more engagement members for engaging the stent bodies to each other when fully expanded. Preferably, the engagement members define a scaffold as previously described.

In some embodiments the stent bodies may each be balloon expandable, self-expandable, or hybrid expandable.

In some embodiments the catheter may comprise one or more expandable members or balloons for expanding and/or seating the stent bodies.

In another embodiment, the invention is directed to a bifurcated stent delivery system comprising a first catheter and a second catheter. The first catheter is configured to deliver a first stent body around the contra lateral wall of a bifurcation site such that the first stent body extends from a primary vessel into the secondary vessel of the bifurcation. A proximal portion of the first stent body is constructed and arranged to be positioned proximal to the carina of the bifurcation, the distal portion of the bifurcated stent is constructed and arranged to extend from the proximal portion into the secondary vessel around the contra lateral wall of the bifurcation. When properly positioned about the contra lateral wall, the side opening of the first stent body is positioned adjacent to the carina of the bifurcation site to provide an open flow path through the primary vessel and proximal portion of the first stent body. Through this primary flow path a second stent body may be positioned and expanded.

In at least one embodiment, when deployed the second stent body extends proximally and distally into the primary vessel extending from the primary flow path defined by the first stent body. Alternatively, in the deployed state the second stent may be positioned to extend only distally or proximally from the first stent body.

In at least one embodiment the second stent engages the portion of the first stent that defines the side opening of the bifurcated stent.

In a least one embodiment the side opening of the first stent body is at least partially defined by a scaffold which is constructed and arranged to engage an end of the second stent body in the expanded state.

In some embodiments, the invention is directed to a stent delivery system which delivers two separate stent bodies to a bifurcation site to form a bifurcated stent assembly. The system comprises a single catheter which has at least two stent retaining regions in linear arrangement. The catheter constructed and arranged to be advance to a bifurcation site, where a distally mounted stent equipped with at least one side opening is deployed from the first stent retaining region. The catheter may then be with drawn from within the deployed stent and re-advanced through the side opening of the stent into the secondary vessel of the bifurcation site. The second stent may then be deployed from the proximally positioned stent retaining region for deployment into the secondary vessel.

In at least one embodiment the primary stent comprises a scaffold which extends into the secondary vessel for engagement with the deployed second stent.

In some embodiments the first stent and the second stent are immediately adjacent to one another in the deployed state.

In some embodiments the deployed stents remain unengaged in the deployed state. Once both stents are deployed from the catheter the catheter may be withdrawn from the deployed stents and bifurcation site.

In the various embodiments of the invention portions of a given catheter and/or stent may include radiopaque materials to aid in visual inspection and/or placement of the devices such as during fluoroscopy.

Additional details and/or embodiments of the invention are discussed below.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A detailed description of the invention is hereafter described with specific reference being made to the drawings.

FIG. 1 is a perspective view of an embodiment of the invention directed to a stent shown in the unexpanded state.

FIG. 2 is a perspective view of the embodiment shown inFIG. 1 wherein the stent is shown in the expanded state.

FIG. 3 is a perspective view of an embodiment of the invention directed to a balloon shown in an expanded configuration wherein the balloon includes a bulge region.

FIG. 4 is a side view of an embodiment of the invention directed to a stent delivery system, the system including a stent delivery catheter shown positioned at a bifurcation site, the catheter having been advanced to the bifurcation site along a primary guide wire, the system including a secondary guide.

FIG. 5 is a close-up view of the catheter shown inFIG. 4.

FIG. 6 is a side view of the stent delivery system shown inFIG. 4, wherein a primary stent is shown in a partially expanded state and the secondary guide wire extending through a side opening of the primary stent into the secondary vessel of the bifurcation site.

FIG. 7 is a side view of the stent delivery system ofFIG. 6 wherein the primary stent is shown in the fully expanded state; a secondary catheter is shown passed through the primary stent into the secondary vessel where a secondary stent is shown partially expanded.

FIG. 8 is a side view of the embodiment shown inFIG. 7 wherein the secondary stent is shown fully expanded, a scaffold structure of the primary stent provides a flow path from the side opening of the primary stent to the secondary stent and is engaged thereto.

FIG. 9 is a side view of an embodiment of the invention directed to a stent delivery system, the system including a stent delivery catheter shown positioned at a bifurcation site and extending into the secondary vessel of the bifurcation, the catheter having been advanced into the secondary vessel along a guide wire, the system including a second guide wire extending into the primary vessel.

FIG. 10 is a side view of an embodiment of a primary stent deployed by the catheter shown inFIG. 9.

FIG. 11 is a side view of an embodiment of a primary stent deployed by the catheter shown inFIG. 9.

FIG. 12 is a side view of the embodiments shown inFIGS. 10 or11 wherein the system further includes a second catheter which is advanced through the proximal portion of the deployed stent through a side opening in the deployed stent.

FIG. 13 is a side view of a second catheter shown inFIG. 12, shown deploying a second stent through the side hole of the previously deployed stent.

FIG. 14 is a side view of an embodiment of the invention wherein a first stent section is deployed at a bifurcation site to extend from a primary vessel into a secondary vessel across the contra lateral wall of the ostium, and a second stent is deployed through the side opening of the first stent and is engaged thereto to extend from the carina into a distal portion of the primary vessel.

FIG. 15 is a side view of an embodiment of the invention wherein a first stent section is deployed at a bifurcation site to extend from a primary vessel into a secondary vessel across the contra lateral wall of the ostium, and a second stent is deployed through the side opening of the first stent to extend from the carina into a distal portion of the primary vessel, the first stent being engaged to the second stent via a scaffold structure extending from the first stent.

FIG. 16 is a side view of an embodiment of the invention wherein a first stent section is deployed at a bifurcation site to extend from a primary vessel into a secondary vessel across the contra lateral wall of the ostium, and a second stent is deployed through the side opening of the first stent and is adjacent thereto to extend from the carina into a distal portion of the primary vessel.

FIG. 17 is a side view of an embodiment of the invention wherein a first stent section is deployed at a bifurcation site to extend from a primary vessel into a secondary vessel across the contra lateral wall of the ostium, and a second stent is deployed through the side opening of the first stent to extend through the flow path defined by the proximal portion of the first stent across the ostium of the secondary vessel.

FIG. 18 is a side view of an embodiment of the invention directed to a catheter for delivering a bifurcated stent assembly to a bifurcation site.

FIG. 19 is a side view of the catheter shown inFIG. 18 wherein a first stent body having a side opening is deployed across the ostium of a secondary vessel.

FIG. 20 is a side view of the catheter shown inFIG. 19 wherein the catheter is advanced back through the first stent body through the side opening and into the secondary vessel.

DETAILED DESCRIPTION OF THE INVENTION

As indicated above the present invention includes many different embodiments. In some embodiments the invention is directed to various designs of bifurcated stents, their delivery systems and methods of use.

InFIG. 1 an embodiment of the invention is shown which comprises a stent, shown generally at10.Stent10 is configured to be mounted on a stent delivery catheter for insertion into a body lumen or vessel and advancement to a bifurcation site.

Stent10 is generally a tubular body having an expandable framework that is self-expandable or balloon expandable. An example of a stent is described in U.S. Pat. No. 6,348,065. When deployed from acatheter stent10 may be expanded from an unexpanded state shown inFIG. 1 to an expanded state shown inFIG. 2.

In the unexpanded state shown inFIG. 1 thestent10, maintains a generally tubular shape defined by astent body12. When in the expanded state shown inFIG. 2 however, a scaffold orstent segment14 extends radially outward from thestent body12 and defines anopening16 through thewall18 of thestent body12. Theopening16 allows asecondary flow path22, defined by thescaffold14, to be in fluid communication with theprimary flow path20 that is defined by thestent body12.

As is shown inFIGS. 1 and 2, theunique side opening16 is defined by ascaffold14.Scaffold14 is defined by a plurality ofstent members24, which in the unexpanded state shown inFIG. 1 are contained substantially within the plane of thestent wall18. When thestent10 is expanded to the expanded state shown inFIG. 2,members24 radially expand outward from thestent body12 to form thescaffold14.

In at least one embodiment, thestent10 is constructed at least partially from metal. Preferably, themembers24 are selectively annealed metal to provide for improved flexibility and actuation.

In at least one embodiment, themembers24 are constructed from one or more shape memory materials that allow themembers24 to self-expand during expansion of thestent body12 thereby formingscaffold14. Suitable shape memory materials may include metals such as nitinol, or shape memory polymers as are known.

In at least one embodiment, thestent10 may be deployed from a catheter having a unique expansion member orballoon30, such as is shown inFIG. 3 (shown in an expanded configuration).Balloon30, may have abody portion32 having that is constructed and arranged to suitably expand thestent body12. However, in at least one embodiment,balloon30 also includes a unique geometry, which in the expanded configuration, comprises abulge region34 that would effectively push againstmembers24 to push the members radially outward from thestent body12 to expand themembers24 to expand outward to form thescaffold14, or alternatively, where the members24 a self-expandable thebulge region34 may be used to trigger the expansion of themembers24 or to lock themembers24 into their final deployed state.

The unique geometry of theballoon30 allows thescaffold14 to be deployed prior to or subsequent to theexpansion stent body12. In at least one embodiment thebulge region34 is defined as a thicker portion and/or thinner portion of the balloon wall that expands under different pressure and/or inflation characteristics relative to thebody portion32. The characteristics of thebulge region34 may be varied to allow thescaffold14 to be deployed prior to, during, or after the expansion of thestent body12 as desired.

As may be seen inFIG. 4, thestent10 may be deployed to abifurcation site40 by acatheter42. Thecatheter42 is advanced through avessel44 and is positioned at thebifurcation site40 such that whenstent10 is deployed, as shown inFIG. 6, thescaffold14 will extend into a secondary vessel orbranch46 and thestent body12 extends across theostium48 of thebranch46.

Typically,catheter42 is advanced to thebifurcation site40 along aguide wire50. In some embodiments, thestent10 or a portion of thecatheter42 includes aradiopaque marker52 which is utilized to aid in accurate visual positioning of the catheter and/or stent at thebifurcation site40, such as by fluoroscopy, etc.

In some embodiments, thecatheter42 includes asecond guide wire54 that is advanced at least partially through thestent body12 as may best be seen inFIG. 5. When thestent10 is expanded, such as is shown inFIG. 6, thesecond guide wire54 is advanced through theside opening16 into thesecondary vessel46.

In some embodiments it may be necessary to provide additional stent support to a portion of thesecondary vessel46. In the embodiment shown inFIG. 7 asecond catheter60 is advanced along thesecond guide wire54 and is at least partially advanced into thesecondary vessel46. Thesecond catheter60, has asecond stent62 mounted thereon.Second stent62 is deployed into thesecondary vessel46 by self-expansion or by balloon expansion, such as is shown.

In at least one embodiment, such as is shown inFIG. 8, thesecond stent62 is positioned within thesecondary vessel46 such that anend64 of the second stent is engaged by thescaffold14 whenstent10 andsecond stent62 are in the expanded state. Thesecond stent62 effectively extends and further defines thesecondary flow path22 of thescaffold14.

In an alternative embodiment of the invention shown inFIG. 9, afirst catheter70 is advanced along afirst guide wire72 which extends through theprimary vessel44 and into thesecondary vessel46.Catheter70 includes afirst stent body74 which is retained on thecatheter70 in an unexpanded state.First catheter70 is advanced to thebifurcation site40 such that thefirst stent body74 is positioned for delivery against the contralateral wall76 of a bifurcation site such that thefirst stent body74 extends from aprimary vessel44 into thesecondary vessel46 of thebifurcation40.

When thefirst stent body74 is deployed, such as is shown inFIG. 10, aproximal portion78 of thefirst stent body74 is positioned proximal to thecarina80 of thebifurcation40. Adistal portion82 of thefirst stent body74 is positioned to extend from theproximal portion78 into thesecondary vessel44 against the contralateral wall76 of thebifurcation40. Proper positioning of thefirst stent body74 and/orcatheter70 may be assisted through the use of one or moreradiopaque markers52 such as described above.

In the expanded state,first stent body74 includes aside opening16 such as previously described. When properly positioned about the contralateral wall76, theside opening16 is positioned adjacent to thecarina80 to provide aprimary flow path20 through theproximal portion78 of the first stent body in fluid communication with theprimary vessel44. Through the primary flow path20 asecond guide wire90 may be advanced.

In at least one embodiment of the invention such as is shown inFIG. 11, theside opening16 is defined by ascaffold14 such as previously described. In the present embodiment, in the expanded state thescaffold14 will extend into theprimary vessel44. When thefirst stent body74 is deployed the-scaffold may be positioned proximally adjacent to thecarina80. In at least one embodiment, thescaffold12 may be constructed to have a sufficient to extend across thecarina80.

After thefirst stent body74 is properly positioned and deployed at thebifurcation site40, in some embodiments a secondstent delivery catheter92 is advanced along thesecond guide wire90 to position asecond stent body94 through theside opening16 such as is shown inFIG. 12. In some embodiments, thesecond catheter92 and/orstent body94 includes a secondradiopaque marker53 to aid in positioning thesecond catheter92 and/orstent body94 relative to the expandedfirst stent body74.

In at least one embodiment, thesecond stent body94 is positioned immediately adjacent to theside opening16 of thefirst stent body74 and is then expanded such as is shown inFIG. 13. As with thefirst stent body74, the second stent body,94 may be a self-expanding stent or a balloon expandable stent as desired.

When thefirst stent body74 andsecond stent body94 are fully expanded such as is shown inFIG. 14, theproximal portion78 of thefirst stent body74 and thesecond stent body94 effectively define a continuousprimary flow path20 via theside opening16. Thedistal portion82 of thefirst stent body74 defines thesecondary flow path22 with in thesecondary vessel46 that is in fluid communication with theprimary flow path20.

As indicated above, in some embodiments, thesecond stent body94 is positioned to be immediately adjacent to thefirst stent body74 such as is shown inFIG. 14.Bodies74 and94 may be frictionally or otherwise engaged to one another. In embodiments where thefirst stent body74 includes ascaffold14, such as is depicted inFIG. 15, thescaffold14 is engaged to theend64 of thesecond stent body94, such as in the manner previously described. In at least one embodiment of the invention, theend64 of thesecond stent body94 is positioned relative to theside opening16 of thefirst stent body74 in such a manner that the two stent bodies have only a partial engagement, such as is shown inFIG. 16. In at least one embodiment thestent bodies74 and94 remain separate and unengaged in the expanded state.

In at least one embodiment of the invention, it may be desired to provide stent support to the primary vessel both proximally and distally of the proximal portion of the first stent body. In such an embodiment, thesecond stent body94 may be a single elongated stent that extends proximally and distally through and beyond theproximal portion78 of thefirst stent body74 such as is shown inFIG. 17. In an alternative embodiment, thesecond stent body94 comprises afirst portion100 and asecond portion102. Prior to expansion and deployment,first portion100 may be advanced through theproximal portion78 of thefirst stent body74 for positioning immediately distal of theside opening16. Thesecond portion102 may be positioned and deployed immediately proximal to theproximal portion78 of thefirst stent body74.Portions100 and102 may be engaged to one another or may define separate and distinct stent bodies. Theportions100 and102 may be respectively engaged toends104 and106 of theproximal portion78 of thefirst stent body74 or they may be separate therefrom.Portions100 and102, like all of the stent bodies described herein may be balloon expandable, self-expandable, hybrid expandable or have a combination of expansion characteristics.

In some embodiments, the invention is directed to a stent delivery system, shown generally at110 inFIG. 18, which includes a singlestent delivery catheter112 that may be utilized to deliver twoseparate stent bodies114 and116 to abifurcation site40 to form a bifurcated stent assembly. In the embodiment shown,catheter112 defines at least twostent retaining regions118 and120 for retaining thestent bodies114 and116 in the unexpanded state on thecatheter112. As is shown, thestent bodies114 and116 are positioned on thecatheter112 in linear series with afirst stent body114 positioned distally in front of thesecond stent body116.

In at least one embodiment the distally mountedstent114 includes aside opening16 such as previously described.

In use thecatheter112 is advanced along aguide wire115 through the vasculature to abifurcation site40. The first or distally mountedstent body114 is deployed in at a desired location, preferably adjacent to theostium48 of thesecondary vessel46, and more preferably at least partially across theostium48 such as is shown inFIG. 19.

After thefirst stent body114 is deployed the guide wire and stent is at least partially withdrawn from the expandedfirst stent body114, and then advanced through theprimary flow path20 defined by thefirst stent body114, through theside opening16, and into thesecondary vessel46.Catheter112 is then advanced along the repositionedguide wire115 into thesecondary vessel46 such as is shown inFIG. 20. Thecatheter112 is positioned to deploy thesecond stent body116 at a desired location within thesecondary vessel46. After both stent bodies have been deployed, thecatheter112 may be withdrawn from the body. In a preferred embodiment, thefirst stent body114 includes a scaffold such as previously described for engaging an end of the second stent body when deployed.

In addition to being directed to the specific combinations of features claimed below, the invention is also directed to embodiments having other combinations of the dependent features claimed below and other combinations of the features described above.

The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims.

Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.

Claims (24)

1. A system comprising:

only a single catheter, the single catheter having only a single balloon, the single catheter being adapted for insertion into a body vessel and advancement to a vessel bifurcation site, wherein the single balloon includes an elongate body region and a pre-formed bulge region that protrudes radially outward from the body region when expanded, the pre-formed bulge region is positioned at a location between a proximal end and a distal end of the body region and at a predetermined location around a circumference of the body region-that extends less than the entire circumference of the body region, wherein the pre-formed bulge region is configured to have different pressure and/or inflation characteristics than the elongate body region; and

a bifurcation stent including a stent body having a substantially tubular stent wall defining a circumferential plane, and a plurality of movable members engaged to the stent wall, each of the moveable members being moveable independent of the other moveable members, the stent body being expandable from an unexpanded condition to an expanded condition by expansion of the single balloon extending within the stent wall from at least a proximal end to at least a distal end of the stent body, in the unexpanded condition the plurality of movable members being retained substantially within the circumferential plane of the stent wall and aligned with the pre-formed bulge region of the single balloon, and in the expanded condition a portion of the plurality of movable members being extended radially outward from the stent wall by expansion of the pre-formed bulge region of the single balloon to form a scaffold, the scaffold defining a side opening in the stent wall;

wherein the pre-formed bulge region is configured to protrude radially outward from the body region independently of whether or not the bifurcated stent is disposed on the single balloon.

2. The system ofclaim 1 wherein the plurality of movable members are characterized as being self-expandable, balloon expandable or hybrid expandable.

3. The system ofclaim 1 wherein at least a portion of the bifurcation stent is constructed from a shape-memory material.

4. The system ofclaim 1 wherein at least a portion of the bifurcation stent is constructed from a metal selected from the group consisting of stainless steel, nitinol, Elgiloy, shape-memory material, and any combination thereof.

5. The system ofclaim 1 wherein when the balloon is expanded the bulge region of the balloon extends the plurality of movable members radially outward from the stent wall to form the scaffold.

6. The system ofclaim 1 wherein the body region of the balloon has a thickness, the thickness of the body region being greater than the thickness of the bulge region.

7. The system ofclaim 1 wherein the body region of the balloon has a thickness, the thickness of the body region being less than the thickness of the bulge region.

8. The system ofclaim 1, wherein the bulge region is positioned on an exterior surface of the body region between the proximal and distal ends of the body region.

9. The system ofclaim 1, wherein the movable members include a shape memory material, and expansion of the single balloon within the stent body activates the shape memory material to move the movable members into the radially outward extended position.

10. A catheter system comprising:

a catheter having a balloon arrangement, the balloon arrangement including an elongate body portion and a pre-formed bulge portion configured to protrude radially outward from the body portion when expanded, the bulge portion being positioned at a location between a proximal end and a distal end of the body region and positioned at a predetermined circumferential location around a circumference of the body region, the bulge portion extending around less than an entire circumference of the body region, wherein the elongate body portion has a first wall thickness and the bulge region has a second wall thickness different than the first wall thickness so that the bulge region has different inflation characteristics than the elongate body region; and

a bifurcation stent including a stent body having a substantially tubular stent wall defining a circumferential plane, and a plurality of movable members engaged to the stent wall, at least one of the moveable members being separate from the other moveable members, the stent wall being expandable from an unexpanded condition to an expanded condition by expansion of the body portion of the balloon arrangement, and the movable members being expandable from an unexpanded position in which the movable members are retained substantially within the circumferential plane to an expanded position extending radially outwardly from the stent wall by expansion of the bulge portion of the balloon arrangement to define a side opening in the stent, wherein the bulge portion is positioned within the circumferential plane prior to expansion of the bulge portion, and after expansion of the bulge portion a portion of the bulge portion extends radially through the side opening outside the circumferential plane.

11. The system ofclaim 10 wherein when the body portion and the bulge portion expand simultaneously.

12. The system ofclaim 10 wherein the body portion of the balloon has a thickness, the thickness of the body portion being greater than a thickness of the bulge portion.

13. The system ofclaim 10 wherein the body portion of the balloon has a thickness, the thickness of the body portion being less than a thickness of the bulge portion.

14. The system ofclaim 10 wherein when the body portion and the bulge portion are integrally formed as a single piece.

15. The system ofclaim 10 wherein the bulge portion has a generally hemispherical structure when expanded.

16. The system ofclaim 10, wherein the bulge portion is positioned on an exterior surface of the body portion between proximal and distal ends of the body portion.

17. The system ofclaim 10, wherein the body portion of the balloon extends coaxially with the stent body.

18. The system ofclaim 10, wherein the body portion of the balloon has a distal end that extends distally of a distal end of the stent body, and a proximal end that extends proximally of a proximal end of the stent body.

19. The system ofclaim 10, wherein the bulge portion extends from within the stent body to a position outside the stent body when expanded.

20. A catheter system comprising:

a catheter having a balloon arrangement, the balloon arrangement including an elongate body portion; and

a bifurcation stent including a stent body having a substantially tubular stent wall defining a circumferential plane, and a plurality of movable members engaged to the stent wall, the movable members configured as self expandable structures that move from an unexpanded position retained substantially within the circumferential plane to an expanded position extending radially outwardly from the stent wall, wherein expansion of the stent wall causes the movable members to move from the unexpanded position to the expanded position, at least a portion of the moveable members expanding towards a proximal end of the stent body and at least a portion of the moveable members expanding towards a distal end of the stent body;

wherein the balloon arrangement further includes a pre-formed bulge portion configured to extend radially outward from the elongate body portion when inflated, the pre-formed bulge portion being positioned at a location between a proximal end and a distal end of the body region and extending around less than an entire circumference of the body portion, the stent positioned relative to the elongate balloon to position the movable members in axial and radial alignment with the pre-formed bulge portion.

21. The catheter system ofclaim 20, wherein the movable members include a shape memory material.

22. The catheter system ofclaim 20, wherein inflation of the bulge portion aids the movable members to move from the unexpanded position to the expanded position.

23. A catheter system, comprising:

only a single catheter, the single catheter having only a single balloon, the single catheter being adapted for insertion into a body vessel and advancement to a vessel bifurcation site, wherein the single balloon includes an elongate body region and a pre-formed bulge region configured to protrude radially outward from the body region when expanded, the pre-formed bulge region is positioned at a location between a proximal end and a distal end of the body region, and positioned at a predetermined circumferential location around a circumference of the body region, the pre-formed bulge region extending less than the entire circumference of the body region; and

a bifurcation stent including a stent body having a substantially tubular stent wall defining a circumferential plane, and a plurality of movable members engaged to the stent wall and movable between an unexpanded position within the circumferential plane and an expanded position extending radially outward from the circumferential plane to define an aperture in the circumferential wall, the single balloon extending within the stent body from at least a distal end to at least a proximal end of the stent wall, the stent wall being expandable by expansion of the body region of the single balloon and the movable members being expandable by expansion of the pre-formed bulge region of the single balloon, wherein a first moveable member extends radially outward at a location distal of the aperture in the circumferential wall and a second moveable member extends radially outward at a location proximal of the aperture.

24. A catheter system for treating a bifurcated vessel, the catheter system comprising:

a stent including a substantially tubular stent body having an open proximal end and an open distal end, wherein a portion of the stent body intermediate the open proximal end and open distal end includes a plurality of movable members configured to move between an unexpanded position and an expanded position, wherein when in the expanded condition, the plurality of moveable member extend radially outward from stent body to define an aperture; and

an inflatable balloon, the inflatable balloon including an elongate body region having a pre-formed bulge region configured to protrude radially outward from the body region when inflated, wherein the bulge region is positioned at a location between a proximal end and a distal end of the body region, and positioned at a predetermined circumferential location around a circumference of the body region, the bulge region extending less than the entire circumference of the body region, wherein the elongate body portion has a first wall thickness and the bulge region has a second wall thickness different than the first wall thickness so that the bulge region has different inflation characteristics than the elongate body region;

wherein the stent is disposed about the balloon such that the bulge region of the balloon is aligned with the plurality of movable members of the stent, wherein the elongate body region of the balloon is configured to expand the tubular stent body when inflated, and the bulge region of the balloon is configured to move the plurality of movable member from the unexpanded position to the expanded position when inflated.

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